Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS

NCT02878655 | Unknown

• 1 other identifier: 14-059
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment. Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis. In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.

Conditions

SCCHN

Keywords

N0 clinical and radiological; dissection IIb sector

Outcome Measures

Primary Outcomes (1)

• Visual Annalogue Scale for Global Quality of Life

  (rate between 0 and 10)

  change over baseline and month 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector

You may qualify if:

• Patient with SCCHN histologically proven N0 clinical and radiological
• Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
• Patient candidate for a neck dissection fonctonnel
• Life expectancy\> 3 months
• Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
• Age over 18 ans
• Patient was informed of the study
• Patient fluent French

You may not qualify if:

• Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
• Patient has at the time of examination of recurrence of signs or other scalable neoplasia
• Uncontrolled Infectious diseases
• Neoadjuvant radiotherapy
• Patient nursing or pregnant or lack of contraception during their reproductive
• Intercurrent pathology involving life-threatening
• Any medical or psychological condition associated that could compromise the patient's ability to participate in the study
• Inability to submit to medical follow-up study for geographical, social or psychic

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

Central Study Contacts

Roger VIVIEN, MD

CONTACT

babin-e@chu-caen.fr

Emmanuel BABIN

CONTACT

babin-e@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: August 25, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

FR (1)